Liver Cancer Clinical Trial
Official title:
A Phase II Study Of rhuMAb VEGF (BEVACIZUMAB) In Patients With Hepatocellular Carcinoma Receiving Chemoembolization
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, cisplatin, and
mitomycin, work in different ways to stop the growth of cancer cells, either by killing the
cells or by stopping the cells from dividing. Chemoembolization kills tumor cells by blocking
the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Monoclonal
antibodies, such as bevacizumab, can kill any tumor cells that are left after
chemoembolization by blocking their ability to grow and spread.
PURPOSE: This randomized phase II trial is studying to see if chemoembolization followed by
bevacizumab works better than chemoembolization alone in treating patients who have liver
cancer that cannot be removed with surgery.
OBJECTIVES:
- Compare neovessel formation at 8 and 14 weeks after hepatic arterial chemoembolization
in patients with unresectable hepatocellular carcinoma treated with bevacizumab versus
no bevacizumab (observation after chemoembolization only).
- Compare time to progression, objective response rate, and tumor marker progression in
patients treated with these regimens.
- Determine the pharmacokinetics of bevacizumab in patients with liver function
impairment.
- Determine the toxic effects of this drug in these patients.
- Compare the cancer biomarker pattern of peripheral blood cells and plasma before and
after chemoembolization in patients treated with these regimens.
OUTLINE: This is a randomized, open-label study.
All patients receive hepatic artery chemotherapy (chemoembolization) comprising doxorubicin
HCl liposome, cisplatin, and mitomycin on day 8 and possibly on day 92. Patients are then
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1
week prior to the first chemoembolization. Courses repeat every 2 weeks in the absence
of disease progression or unacceptable toxicity.
- Arm II: Patients do not receive bevacizumab. Patients in arm II may cross-over receive
bevacizumab as in arm I if recurrent tumor is evident at week 14 by CT scan or MRI or a
50% or greater increase in AFP level has occurred since day 8 chemoembolization.
PROJECTED ACCRUAL: A total of 30 patients (15 per treatment arm) will be accrued for this
study.
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